Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (3): 136-139.

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Impact on QTc Interval and Safety Evaluation of Amiodarone Injection for Inpatients

ZHANG Xiao -xing1, ZHANG Li -ming2 ,ZHENG Qing -min3, JI Li-wei4 ,DING Qing -ming5, LIU Yu -qing1 ,LOU Ying1 ,LI Yi-shi1   

  1. 1.Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fu Wai Hospital, CAMS & PUMC, Beijing 100037, China;
    2.Beijing Center for ADR Monitoring, Beijing 100024, China;
    3.Beijing An Zhen Hospital of the Capital University of Medical Sciences, Beijing 100029, China;
    4.Beijing Hospital of the Ministry of Health, Beijing 100005, China;
    5China-Japan Friendship Hospital of the Ministry of Health, Beijing 100029, China
  • Received:2013-01-21 Revised:2016-03-09 Online:2013-03-08 Published:2016-03-09

Abstract: Objective To evaluate the impact on QTc interval and relevant adverse drug reaction of amiodarone injeon for inpatients. Methods 1 111 inpatients from 4 upper first class hospitals in Beijing were enrolled from May 2011 to July 2012, the QTc intervals were measured to evaluate whether there would be change before and after amiodarone injection within 24 hours, and suspected proarrhythmia adverse effects due to study drug were monitored during the entire period of administration. Results The average heart rate was slowed(87.4±21.2bpm vs 99.6±27.9bpm, P<0.001) and QT interval was prolonged(388.5±55.9ms vs 366.0±55.9ms, <0.001) significantly after amiodarone administration as compared with the baseline, but QTc interval was not changed with statistical significance(456.8±51.0ms vs 457.8±50.2ms, P=0.554). One patient with atrial tachycardia experienced TdP after 54 hours amiodarone injection concomitant with oral amiodarone showed a prolonged QTc interval up to 756ms previously,TdP didn't occur again after amiodarone discontinuation and appropriate treatment. Conclusion Amiodarone injection within 24 hours does not impact on QTc interval with statistical significance in inpatients. Electrocardiograph should be monitored in a continuous amiodarone injection to avoid the relevant adverse drug reaction, especially when using oral amiodarone concomitantly.

Key words: amiodarone injection, QTc interval, adverse drug reaction(ADR), TdP

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